Ortho Biotech is recalling one manufacturing lot (P114942A) of (Epoetin alfa) after having identified cracks in the necks of a small number of vials upon post-manufacturing inspection. Approximately 44,292 vials of lot P114942A in the following packaging configurations were distributed between April 15, 2008 and July 17, 2008. No other lot of this product is affected by this recall.

Vials exhibiting even slight cracks may not maintain their sterile condition and should not be used for subcutaneous or intravenous injection.

The amount of PROCRIT being withdrawn represents a very small proportion of the total product within the distribution channel; therefore the company does not anticipate a disruption in product availability for patients.